Medical Device Cap for Drug Transfer Assembly

ABSTRACT

A medical device cap that protectively surrounds a medical device component for disinfection purposes and includes an identification element that can record and transmit pertinent information of the medical device cap and the medical device component is disclosed. The medical device cap enables documentation of instances when the cap is used and promotes stronger compliance with the use of medical device caps for applications involving disinfection of a medical device component such as an IV access port or a luer tip. Use of the medical device cap results in better compliance and monitoring of the use of such caps and leads to reduced incidence of CRBSI infections related to medical device component contamination. In one embodiment, the medical device cap enables automated real-time electronic documentation of when the cap is applied, while also documenting duration of application and tracking of device for inventory management.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority to U.S. Provisional ApplicationSer. No. 62/057,001, entitled “Medical Device Cap for Drug TransferAssembly”, filed Sep. 29, 2014, the entire disclosure of which is herebyincorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Disclosure

The present disclosure relates generally to components of a drugtransfer assembly. More particularly, the present disclosure relates toa medical device cap for protectively surrounding and shielding amedical device component and that includes an identification elementthat records and transmits information.

2. Description of the Related Art

Disposable antimicrobial sanitizing caps that couple with an IV accessport are used for applications involving disinfection of the IV accessport. Such devices have been designed to reduce the incidence ofCatheter Related Blood Stream Infections (CRBSI) by swabbing andprotecting the port to prevent and eliminate microbial migration fromthe surface of the port to the blood stream. However, not properlycleaning and disinfecting the IV access port may contribute to CRBSIinfections.

CRBSI infections have a tremendous cost impact on health careinstitutions. Furthermore, these institutions are not able to easilytrack the compliance around disinfection of IV access ports betweenaccess of the ports. As medical practitioner shifts change in certainacute care settings, such as the ICU, inaccurate or incomplete recordsmay be handed off from one medical practitioner to another. As such, thehealth care institution may be unable to track the compliance andutilization of technologies, such as protector caps to reduce CRBSIincidents.

SUMMARY OF THE INVENTION

The present disclosure provides a medical device cap that protectivelysurrounds a medical device component for disinfection purposes andincludes an identification element that can record and transmitpertinent information of the medical device cap and the medical devicecomponent. The medical device cap of the present disclosure enablesdocumentation of instances when the cap is used and promotes strongercompliance with the use of medical device caps for applicationsinvolving disinfection of a medical device component such as an IVaccess port or a luer tip. In this manner, use of the medical device capof the present disclosure results in better compliance and monitoring ofthe use of such caps and leads to reduced incidence of CRBSI infectionsrelated to medical device component contamination. In one embodiment,the medical device cap enables automated real-time electronicdocumentation of when the cap is applied, while also documentingduration of application and tracking of the device for inventorymanagement.

In accordance with an embodiment of the present invention, an IV accessport cap for a drug transfer assembly includes a cap body removablyconnectable with an IV access port and an identification elementdisposed on the cap body, wherein with the cap body connected to the IVaccess port, the identification element records information.

In one configuration, with the cap body connected to the IV access port,the identification element transmits the information to a receiver. Inanother configuration, with the cap body removed from the IV accessport, the identification element records additional information. In yetanother configuration, with the cap body removed from the IV accessport, the identification element transmits the additional information toa receiver. In one configuration, with the cap body connected to the IVaccess port, the cap body protectively surrounds at least a portion ofthe IV access port. In another configuration, the identification elementcomprises a barcode. In yet another configuration, the identificationelement comprises an RFID. In one configuration, the information is timeduration. In another configuration, the information is frequencyinformation. In yet another configuration, at least a part of theinformation comprises IV access port cap information. In oneconfiguration, the IV access port cap further includes a disinfectingsponge disposed inside the cap body.

In accordance with another embodiment of the present invention, amedical device cap for a drug transfer assembly includes a cap bodyremovably connectable with a luer tip and an identification elementdisposed on the cap body, wherein with the cap body connected to theluer tip, the identification element records information.

In one configuration, with the cap body connected to the luer tip, theidentification element transmits the information. In anotherconfiguration, with the cap body removed from the luer tip, theidentification element records additional information. In yet anotherconfiguration, with the cap body removed from the luer tip, theidentification element transmits the additional information to areceiver. In one configuration, with the cap body connected to the luertip, the cap body protectively surrounds at least a portion of the luertip. In another configuration, the identification element comprises abarcode. In yet another configuration, the identification elementcomprises an RFID. In one configuration, the information is timeduration. In another configuration, the information is frequencyinformation. In yet another configuration, at least a part of theinformation comprises medical device cap information. In oneconfiguration, the medical device cap further includes a disinfectingsponge disposed inside the cap body.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of a medical device cap of a drug transferassembly in accordance with an embodiment of the present invention.

FIG. 2A is a perspective view of a medical device cap of a drug transferassembly in accordance with another embodiment of the present invention.

FIG. 2B is an enlarged view of a barcode of the medical device cap ofFIG. 2A in accordance with an embodiment of the present invention.

FIG. 3 is a perspective view of the medical device cap of FIG. 2Aconnected to an IV access port and a scanner reading the barcode of themedical device cap in accordance with an embodiment of the presentinvention.

FIG. 4 is a cross-sectional view of a medical device cap connected to aluer tip in accordance with an embodiment of the present invention.

FIG. 5 is a cross-sectional view of a medical device cap connected to anIV access port in accordance with an embodiment of the presentinvention.

FIG. 6 is an assembled, perspective view of a drug transfer assembly inaccordance with an embodiment of the present invention.

FIG. 7 is a perspective view of the drug transfer assembly of FIG. 6with the drug transfer assembly provided to a patient in accordance withan embodiment of the present invention.

FIG. 8 is an exploded, perspective view of the drug transfer assembly ofFIG. 7 with a medical device cap for connection with an IV access portof the drug transfer assembly removed in accordance with an embodimentof the present invention.

FIG. 9 is a perspective view of the drug transfer assembly of FIG. 7with an injector connected to the IV access port of the drug transferassembly in accordance with an embodiment of the present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

FIG. 1 illustrates a medical device cap 10 according to an exemplaryembodiment of the present disclosure. The medical device cap 10generally includes a cap body 12 defining a cap exterior wall 14 and acap interior wall 16, respectively corresponding to the exterior profileand the interior profile of medical device cap 10. Referring to FIGS. 4and 5, the cap interior wall 16 defines a cavity 18 which is sized andshaped to receive a medical device component therein as described inmore detail below. The cap body 12 includes an identification element 20disposed on the cap body 12 for recording and transmitting informationas discussed below. In one embodiment, the identification element 20 isdisposed on the cap exterior wall 14 of the cap body 12.

The cap exterior wall 14 may include a plurality of grip elements 22extending around a periphery of the cap body 12 to facilitate thehandling of the medical device cap 10 by a medical practitioner. In oneembodiment, the plurality of grip elements 22 include ribs 28 whichprovide a gripping means to allow a medical practitioner to more easilygrasp the medical device cap 10 when connecting the medical device cap10 to a medical device component. The grip elements 22 also provide agripping means to allow a medical practitioner to more easily grasp themedical device cap 10 when removing the medical device cap 10 from amedical device component. Referring to FIGS. 4 and 5, the medical devicecap 10 includes a disinfecting sponge 24 disposed within the cavity 18.The disinfecting sponge 24 includes powerful cleaning and disinfectingagents that are released to contact a medical device component when themedical device cap 10 is connected to a medical device component. Forexample, referring to FIGS. 4 and 5, with a medical device cap 10connected to a respective luer tip 150 or IV access port 160, thedisinfecting sponge 24 contacts the respective luer tip 150 or IV accessport 160 thereby releasing the powerful cleaning and disinfecting agentsto the respective luer tip 150 or IV access port 160.

In one embodiment, the identification element 20 is a radio-frequencyidentification (RFID) element 26 that is disposed on the cap exteriorwall 14 of the cap body 12 as shown in FIG. 1. In one embodiment, theRFID element 26 is a passive RFID label on the cap exterior wall 14 thatis capable of emitting a signal when in close proximity to an activeRFID, label on the patient, or on the medical device component such asthe IV access port or the luer tip. In this manner, the RFID element 26is able to record and transmit compliance information related to themedical device cap 10 and/or the medical device component automaticallyupon connection of the medical device cap 10 with the medical devicecomponent. The identification element 20 may be adapted to transmit theinformation to a receiver, such as a scanner 180. The transmission ofinformation may occur automatically, or may occur upon activation of theidentification element 20. Additionally, the RFID element 26 is able torecord and transmit compliance information related to the medical devicecap 10 and/or the medical device component automatically upon removal ofthe medical device cap 10 from the medical device component.

The RFID element 26 of the medical device cap 10 is capable of recordingand transmitting pertinent information of the medical device cap 10 andthe medical device component. The medical device cap 10 that includesthe. RFID element 26 enables documentation of instances when the medicaldevice cap 10 is used and promotes stronger compliance with the use ofthe medical device cap 10 for applications involving disinfection of amedical device component such as an IV access port or a luer tip. Inthis manner, use of the medical device cap 10 that includes the RFIDelement 26 results in better compliance and monitoring of the use of themedical device cap 10 and leads to reduced incidence of CRBSI infectionsrelated to medical device component contamination. In one embodiment,the medical device cap 10 that includes the RFID element 26 enablesautomated real-time electronic documentation of when the medical devicecap 10 is connected to a medical device component, while alsodocumenting duration of application and tracking of device for inventorymanagement.

The medical device cap 10 of the present disclosure also provides amedical device cap that protectively surrounds a medical devicecomponent for disinfection purposes. Referring to FIGS. 3-7, the medicaldevice cap 10 protectively surrounds and shields a medical devicecomponent to prevent contact between the medical device component and anundesired surface and to prevent contamination of the medical devicecomponent of the drug transfer assembly 100. With the medical device cap10 connected to the medical device component, the medical devicecomponent is protectively shielded from exposure to the environment andthe medical device cap 10 is prevented from becoming contaminated withundesirables.

The cap body 12 of an exemplary embodiment is preferably made of apliable material, such as a soft rubber or pliable plastic, for example.In one exemplary embodiment, the cap body 12 is made from thermoplasticelastomers such as styrenic block copolymers, polyolefin blends &alloys, thermoplastic polyurethanes, thermoplastic copolyesters,thermoplastic polyamides, or similar materials. In other embodiments,the cap body 12 is made from thermosetting elastomers (rubbers) such assilicone, polyisoprene, neoprene, or similar materials. The cap body 12may be injection molded using TPE elastomers or liquid rubber injectedor casted using silicones.

In one embodiment, the medical device cap 10 is removably connectablewith a medical device component. For example, the medical device cap 10is removably connectable with a luer tip 150 as shown in FIG. 4. Inanother embodiment, the medical device cap 10 is removably connectablewith an IV access port 160 as shown in FIG. 5. In other embodiments, themedical device cap 10 is removably connectable with other medical devicecomponents. For example, the medical device cap 10 is compatible withother components of closed system drug transfer devices.

In one embodiment, the medical device cap 10 could be packagedseparately from the other components of a drug transfer assembly 100. Inanother embodiment, the medical device cap 10 could be “pre-packaged”and come already attached to a medical device component of a drugtransfer assembly 100. In one embodiment, the medical device cap 10could be a disposable cap.

FIG. 2A illustrates a medical device cap 40 according to anotherexemplary embodiment of the present disclosure. The medical device cap40 generally includes a cap body 42 defining a cap exterior wall 44 anda cap interior wall 46 (FIGS. 4-6), respectively corresponding to theexterior profile and the interior profile of the medical device cap 40.Referring to FIGS. 4 and 5, the cap interior wall 46 defines a cavity 48which is sized and shaped to receive a medical device component thereinas described in more detail below. The cap body 42 includes anidentification element 50 disposed on the cap body 42 for recording andtransmitting information as discussed below. In one embodiment, theidentification element 50 is disposed on the cap exterior wall 44 of thecap body 42.

The cap exterior wall 44 may include a plurality of grip elements 52extending around a periphery of the cap body 42 to facilitate thehandling of the medical device cap 40 by a medical practitioner. In oneembodiment, the plurality of grip elements 52 includes ribs 58 whichprovide a gripping means to allow a medical practitioner to more easilygrasp the medical device cap 40 when connecting the medical device cap40 to a medical device component. The grip elements 52 also provide agripping means to allow a medical practitioner to more easily grasp themedical device cap 40 when removing the medical device cap 40 from amedical device component. Referring to FIGS. 4 and 5, the medical devicecap 40 includes a disinfecting sponge 54 disposed within the cavity 48.The disinfecting sponge 54 includes powerful cleaning and disinfectingagents that are released to contact a medical device component when themedical device cap 40 is connected to a medical device component. Forexample, referring to FIGS. 4 and 5, with a medical device cap 40connected to a respective luer tip 150 or IV access port 160, thedisinfecting sponge 54 contacts the respective luer tip 150 or IV accessport 160 thereby releasing the powerful cleaning and disinfecting agentsto the respective luer tip 150 or IV access port 160.

In one embodiment, the identification element 50 is a barcode 56 that isdisposed on the cap exterior wall 44 of the cap body 42 as shown inFIGS. 2A and 2B. In one embodiment, the medical device cap 40 includes aunique barcode label 56 and is able to record and transmit complianceinformation related to the medical device cap 40 and/or the medicaldevice component upon connection of the medical device cap 40 with themedical device component. Additionally, the barcode 56 is able to recordand transmit compliance information related to the medical device cap 40and/or the medical device component upon removal of the medical devicecap 40 from the medical device component.

For example, when a medical practitioner connects the medical device cap40 to a medical device component, such as an IV access port, the medicalpractitioner can scan the barcode 56 of the medical device cap 40 with ascanner 180 (FIG. 3) to record the unique ID assigned to that particularmedical device cap 40 with a time stamp. When it is time to remove themedical device cap 40 to administer medication, or replace with a newmedical device cap, the barcode 56 of the medical device cap 40 will bescanned again to record the duration and frequency of medical devicecaps used throughout a patient's hospital or in-patient stay.

Alternatively, the scanner can reside either separately with the medicalpractitioner, attached to a BCMA machine, or reside independently on thepatient near the medical device component such as an IV access port.Examples of an IV access port include a peripheral IV catheter, aperipherally inserted central catheter, or a central venous catheter.

The barcode 56 of the medical device cap 40 is capable of recording andtransmitting pertinent information of the medical device cap 40 and themedical device component. The medical device cap 40 that includes thebarcode 56 enables documentation of instances when the medical devicecap 40 is used and promotes stronger compliance with the use of themedical device cap 40 for applications involving disinfection of amedical device component such as an IV access port or a luer tip. Inthis manner, use of the medical device cap 40 that includes the barcode56 results in better compliance and monitoring of the use of the medicaldevice cap 40 and leads to reduced incidence of CRBSI infections relatedto medical device component contamination. In one embodiment, themedical device cap 40 that includes the barcode 56 enables automatedreal-time electronic documentation of when the medical device cap 40 isconnected to a medical device component, while also documenting durationof application and tracking of device for inventory management.

The medical device cap 40 of the present disclosure also provides amedical device cap that protectively surrounds a medical devicecomponent for disinfection purposes. Referring to FIGS. 3-7, the medicaldevice cap 40 protectively surrounds and shields a medical devicecomponent to prevent contact between the medical device component and anundesired surface and to prevent contamination of the medical devicecomponent of the drug transfer assembly 100. With the medical device cap40 connected to the medical device component, the medical devicecomponent is protectively shielded from exposure to the environment andthe medical device cap 40 is prevented from becoming contaminated withundesirables.

The cap body 42 of an exemplary embodiment is preferably made of apliable material, such as a soft rubber or pliable plastic, for example.In one exemplary embodiment, the cap body 42 is made from thermoplasticelastomers such as styrenic block copolymers, polyolefin blends andalloys, thermoplastic polyurethanes, thermoplastic copolyesters,thermoplastic polyamides, or similar materials. In other embodiments,the cap body 42 is made from thermosetting elastomers such as silicone,polyisoprene, neoprene, or similar materials. The cap body 42 may beinjection molded using TPE elastomers or liquid rubber injected orcasted using silicones.

In one embodiment, the medical device cap 40 is removably connectablewith a medical device component. For example, the medical device cap 40is removably connectable with a luer tip 150 as shown in FIG. 4. Inanother embodiment, the medical device cap 40 is removably connectablewith an IV access port 160 as shown in FIG. 5. In other embodiments, themedical device cap 40 is removably connectable with other medical devicecomponents. For example, the medical device cap 40 is compatible withother components of closed system drug transfer devices.

In one embodiment, the medical device cap 40 could be packagedseparately from the other components of a drug transfer assembly 100. Inanother embodiment, the medical device cap 40 could be pre-packaged andbe provided as already attached to a medical device component of a drugtransfer assembly 100. In one embodiment, the medical device cap 40could be a disposable cap.

As discussed above, a medical device cap 10, 40 of the presentdisclosure is removably connectable with a medical device component. Forexample, in one embodiment, the medical device cap 10, 40 is removablyconnectable with a luer tip 150 as shown in FIG. 4. In anotherembodiment, the medical device cap 10, 40 is removably connectable withan IV access port 160 as shown in FIG. 5. In other embodiments, themedical device cap 40 is removably connectable with other medical devicecomponents. For example, the medical device cap 40 is compatible withother components of closed system drug transfer devices.

Referring to FIGS. 6-9, in one embodiment, a medical device cap 10, 40of the present disclosure is removably connectable with a medical devicecomponent of a drug transfer assembly 100. The drug transfer assembly100 includes an IV access port 102 and an intravenous line 112 adaptedfor connection to a bloodstream of a patient P. Drug transfer assembly100 further includes a patient portion 113 of intravenous line 112, afirst connector 114 connected to a first portion 116 of intravenous line112, a second connector 118 connected to a second portion 120 ofintravenous line 112, an intravenous line connector 122 for connectingin fluid communication patient portion 113 of intravenous line 112 withfirst portion 116 and second portion 120 of intravenous line 112, apatient connector 124 disposed at a patient end 126 of intravenous line112, and a medical device cap 10, 40 of the present disclosure isremovably connectable with a medical device component of the drugtransfer assembly 100. For example, the medical device cap 10, 40 isremovably connectable with IV access port 102 as shown in FIGS. 6-8.

Referring to FIGS. 6-9, in one embodiment, intravenous line 112 maycomprise sections of flexible plastic tubing. The sections of plastictubing may be connected in fluid communication by intravenous lineconnector 122. In one embodiment, intravenous line connector 122 maycomprise a Y-shape as shown in FIG. 6. In another embodiment,intravenous line connector 122 may comprise a T-shape as shown in FIGS.7-9. Further, it is contemplated that intravenous line connector 122 maybe made available in a variety of shapes and sizes to accommodatesections of plastic tubing so that first connector 114 and secondconnector 118 are spaced a distance from one another.

In one embodiment, first connector 114 comprises a connector which iscompatible with components of closed system drug transfer devices. Inone embodiment, second connector 118 comprises an intravenous bagconnector which is adapted to receive an intravenous bag containing amedication. In other embodiments, second connector 118 comprises aconnector which is compatible with components of closed system drugtransfer devices.

Referring to FIG. 6, in one embodiment, drug transfer assembly 100further includes a clamp 128 which can be used to temporarily restrictthe flow of fluid within second portion 120 of the intravenous line 112.

The drug transfer assembly 100 of the present disclosure may be usedwith personal intravenous therapy applications that allow patients toreceive infusion and medication treatment at home, although the drugtransfer assembly 100 may also be used in any medical care setting. Hometherapies may include the administration of medications by IV usingintravenous and subcutaneous or hypodermis routes, i.e., into thebloodstream and under the skin. Examples of medical treatments thatpersonal intravenous therapy applications may provide to a patientinclude antibiotics, pain management medications, cancer treatments, andsimilar medications.

Medications may be packaged as pre-filled devices, wherein a syringeassembly is pre-filled with medication prior to being packaged anddelivered to a patient. Such pre-filled devices eliminate the need for auser to fill the device prior to injection.

Certain drugs or medications are preferably provided in powder or dryform (such as a lyophilized form), and require reconstitution prior toadministration. Lyophilized drugs, for example, typically are suppliedin a freeze-dried form that require mixing with a diluent toreconstitute the substance into a form that is suitable for injection.In addition, drugs may be provided as multipart systems that requiremixing prior to administration. For example, one or more liquidcomponents, such as flowable slurries, and one or more dry components,such as powdered or granular components, may be provided in separatecontainers that require mixing prior to administration.

Referring to FIG. 9, drug transfer assembly 100 includes an injector 140that is removably connectable with IV access port 102 via firstconnector 114 and a syringe assembly 142 containing a medication orfluid 144. Medication 144 can be packaged within syringe assembly 142 asa “pre-filled” device or medication 144 may be a reconstitutedmedication as discussed above. Once the medication 144 is containedwithin syringe assembly 142, the medication 144 is ready foradministration to a bloodstream of a patient such as patient P (FIGS.7-9). Once a patient or medical practitioner is ready to administer themedication 144, the patient or medical practitioner may remove a medicaldevice cap 10, 40 (FIG. 8) from IV access port 102 as will be describedin further detail below.

Referring to FIG. 9, the patient P may then connect injector 140 to theIV access port 102 via first connector 114 that is connected to firstportion 116 of intravenous line 112 of drug transfer assembly 100.Syringe assembly 142 may then be connected with injector 140. In oneembodiment, injector 140 and syringe assembly 142 form a singlecomponent that is connected to the IV access port 102 via firstconnector 114. With injector 140 connected to the IV access port 102 viafirst connector 114, first connector 114 provides a secure, closedconnection with injector 140 and syringe assembly 142 at the IV accessport 102 that provides a leak-proof seal throughout a drug transferprocedure. Further, first connector 114 connects, in fluidcommunication, injector 140 and syringe assembly 142 with intravenousline 112 as shown in FIG. 9. In this manner, the patient P may injectmedication 144 to their bloodstream. In such an embodiment, medication144 can be injected into patient P through syringe assembly 142 toinjector 140 to the IV access port 102 via first connector 114 andthrough first portion 116 of intravenous line 112 to intravenous lineconnector 122 to patient portion 113 of intravenous line 112 and throughpatient connector 124 at patient end 126 of intravenous line 112 to thebloodstream of the patient P in a secured, leak-proof, closedconnection, i.e., in a manner such that no outside contaminants canenter into the drug transfer assembly 100 and such that no medicationmay leak from drug transfer assembly 100 during its travel through theabove-described flow path.

Once the dose of medication has been administered, injector 140 andsyringe assembly 142 are removed from first connector 114. In thisconfiguration, IV access port 102 is exposed to the environment and maybecome contaminated with undesirables. To eliminate the IV access port102 being exposed to the environment and becoming contaminated withundesirables, a medical device cap 10, 40 of the present disclosure isconnected to the IV access port 102 via first connector 114 when apatient is done administering a dose of medication as shown in FIG. 7.In this manner, a medical device cap 10, 40 of the present disclosureprotectively surrounds and shields the IV access port 102 to preventcontamination of the N access port 102.

A medical device cap 10, 40 of the present disclosure also is able torecord and transmit information when the medical device cap 10, 40 isconnected to the N access port 102. For example, a medical device cap10, 40 is able to record and transmit a first piece of information whenthe medical device cap 10, 40 is connected to the IV access port 102.The first piece of information may comprise any information related tothe medical device cap, the medical device component that the medicaldevice cap is being coupled to, or the coupling event between themedical device cap and the medical device component. For example, thefirst piece of information may comprise time information, frequencyinformation, medical device cap information, medical device componentinformation, or other pertinent information.

A medical device cap 10, 40 of the present disclosure is uniquely taggedwith an identification element such that variables related to theapplication of the medical device cap to a medical device component canbe documented by reading the unique identification to obtain informationcontained within. When the medical device cap 10, 40 mates with an IVaccess port, a medical device with a luer tip, or other medical devicecomponent, the coupling event can be recorded and electronicallydocumented to enable compliance and reduce infections. The couplingevent can be recorded through technologies including, but not limitedto, barcoding and RFID as described above. Better compliance andmonitoring of the use of such medical device caps leads to reducedincidence of CRBSI related to IV access port contamination.

A medical device cap 10, 40 of the present disclosure through the uniqueidentification technology coupled with an ID-decoding technology, wouldenable automated real-time electronic documentation of when the medicaldevice cap is applied, while also documenting duration of applicationand tracking of devices for inventory management.

A medical device cap 10, 40 of the present disclosure also is able torecord and transmit information when the medical device cap 10, 40 isremoved from the IV access port 102. For example, a medical device cap10, 40 is able to record and transmit a second piece of information whenthe medical device cap 10, 40 is removed from the IV access port 102.The second piece of information may comprise any information related tothe medical device cap, the medical device component that the medicaldevice cap is being coupled to, or the coupling event between themedical device cap and the medical device component. For example, thesecond piece of information may comprise time information, frequencyinformation, medical device cap information, medical device componentinformation, or other pertinent information.

As discussed above, a medical device cap 10, 40 of the presentdisclosure is removably connectable with a medical device component.Referring to FIG. 4, in one embodiment, the medical device cap 10, 40 isremovably connectable with a luer tip 150. In one embodiment, themedical device cap is a luer tip cap or a medical device cap that isremovably connectable with luer tip 150.

Referring to FIG. 5, in another embodiment, the medical device cap 10,40 is removably connectable with an IV access port 160. In oneembodiment, the medical device cap is an IV access port cap or a medicaldevice cap that is removably connectable with IV access port 160.

Referring to FIGS. 4, 5, and 7, in an exemplary embodiment, a medicaldevice cap 10, 40 and a medical device component are secured together byan interference fit connection to provide a secure fit therebetween,such that a medical device cap 10, 40 protectively surrounds and shieldsthe medical device component to prevent contamination of the medicaldevice component.

Referring to FIGS. 4 and 5, cap body 12 of medical device cap 10 and capbody 42 of medical device cap 40 are each sized and shaped tosubstantially correspond to an exterior profile 155 of luer tip 150 oran exterior profile 165 of IV access port 160. This interference fitbetween a medical device cap 10, 40 and a respective medical devicecomponent 150, 160 is achieved by sizing and shaping the two matingparts, i.e., the interior profile of a cap body 12, 42 of a medicaldevice cap 10, 40 and the exterior profile 155, 165 of a medical devicecomponent 150, 160 so that the interior profile of cap body 12, 42 ofmedical device cap 10, 40 only slightly deviates dimensionally from theexterior profile 155, 165 of a medical device component 150, 160. Thisensures an interference fit that secures a cap body 12, 42 of a medicaldevice cap 10, 40 and a respective medical device component 150, 160together by a friction force after insertion of a medical devicecomponent 150, 160 into a selected medical device cap 10, 40 as shown inFIGS. 4 and 5.

In other embodiments, a medical device cap 10, 40 and a medical devicecomponent are secured together by other connection means to provide asecure fit therebetween, such that a medical device cap 10, 40protectively surrounds and shields the medical device component toprevent contamination of the medical device component. For example, inother embodiments, the connection means may include a threaded portion,a snap fit mechanism, a ball detent, locking tabs, a spring loadedlocking mechanism, latch, adhesive, or other similar mechanism.

A medical device cap 10, 40 of the present disclosure includes a uniqueidentification element that contains information unique to that specificdevice and is capable of recording and transmitting any informationrelated to the medical device cap, the medical device component that themedical device cap is being coupled to, or the coupling event betweenthe medical device cap and the medical device component. Thisinformation can be read by a machine with certain capabilities to readthe unique identification element of the medical device cap andelectronically disseminating information for documentation purposes. Forexample, referring to FIG. 3, scanner 180 may be utilized for laserscanning of the barcodes. Additionally, the information can be read fromthe unique identification element of the medical device cap when thecoupling of the medical device cap takes place with a medical devicecomponent and when the medical device cap is removed from the medicaldevice component.

In other embodiments, a similar use of a unique identification elementthat contains information unique to that specific device and is capableof recording and transmitting information can also be used with IVaccess ports (Q-style) to enable documentation or coupling betweenuniquely tagged devices for compliance and/or inventorytracking/utilization purposes. In one embodiment, together with a Flushsyringe, also having a similar unique identification element, a usercould document any interaction between a device and an IV access portthrough the same principles as described above.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. An IV access port cap for a drug transferassembly, the IV access port cap comprising: a cap body removablyconnectable with an IV access port; and an identification elementdisposed on the cap body, wherein with the cap body connected to the IVaccess port, the identification element records information.
 2. The IVaccess port cap of claim 1, wherein with the cap body connected to theIV access port, the identification element transmits the information toa receiver.
 3. The IV access port cap of claim 1, wherein theidentification element automatically records information.
 4. The IVaccess port cap of claim 1, wherein the identification element recordsinformation upon electronic activation.
 5. The IV access port cap ofclaim 1, wherein with the cap body removed from the IV access port, theidentification element records additional information.
 6. The IV accessport cap of claim 5, wherein with the cap body removed from the IVaccess port, the identification element transmits the additionalinformation to a receiver.
 7. The IV access port cap of claim 5, whereinthe additional information is a frequency that the cap body isdisconnected from the IV access port.
 8. The IV access port cap of claim1, wherein with the cap body connected to the IV access port, the capbody protectively surrounds at least a portion of the IV access port. 9.The IV access port cap of claim 1, wherein the identification elementcomprises a barcode.
 10. The IV access port cap of claim 1, wherein theidentification element comprises an RFID.
 11. The IV access port cap ofclaim 1, wherein the information is a duration of time.
 12. The IVaccess port cap of claim 1, further comprising a disinfecting spongedisposed inside the cap body.
 13. A medical device cap for a drugtransfer assembly, the medical device cap comprising: a cap bodyremovably connectable with a luer tip; and an identification elementdisposed on the cap body, wherein with the cap body connected to theluer tip, the identification element records information.
 14. Themedical device cap of claim 13, wherein with the cap body connected tothe luer tip, the identification element transmits the information to areceiver.
 15. The medical device cap of claim 13, wherein with the capbody removed from the luer tip, the identification element recordsadditional information.
 16. The medical device cap of claim 15, whereinwith the cap body removed from the luer tip, the identification elementtransmits the additional information to a receiver.
 17. The medicaldevice cap of claim 13, wherein with the cap body connected to the luertip, the cap body protectively surrounds at least a portion of the luertip.
 18. The medical device cap of claim 13, wherein the identificationelement comprises a barcode.
 19. The medical device cap of claim 13,wherein the identification element comprises an RFID.
 20. The medicaldevice cap of claim 13, wherein the information is time duration. 21.The medical device cap of claim 13, wherein the information is frequencyinformation.
 22. The medical device cap of claim 13, further comprisinga disinfecting sponge disposed inside the cap body.